QMS documentation
The whole controlled document set, written to FDA QMSR and ISO 13485 — and structured so the people who have to follow it can read it without a translator.
- SOPs
- Work instructions
- Forms
- QMSR
- ISO 13485
Quality systems that hold up when someone checks.
We write the procedures, run the gap assessments, and sit with your team through the audit — for companies drafting their first SOP, and for the ones already running four sites in three jurisdictions.
Why Kairos
Every quality problem has a cheapest moment to fix it. Almost none of them get found there.
Concept
A decision
Design controls
A redline
Verification
A re-test
Submission
A deficiency letter
Inspection
A Form 483
Post-market
A recall
The premise
Kairos is the Greek word for the right moment to act — the one that doesn't come back. Regulatory work rewards that idea more literally than most fields: the same finding costs an afternoon in design controls and a year after clearance. Our job is to move your problems left.
§ 1 Scope
What we do
Six areas of work. Most engagements start in one and spread into the next two.
Validation
Protocols and reports written from scratch, or reviewed against what you already have. The rationale gets spelled out rather than assumed, which is where most of them fail.
- IQ / OQ / PQ
- Cleaning
- CSV / CSA
- Process
QMS build-out
For companies with no system yet, and for the ones whose system grew by accident. We take it from assessment through to a released, trained-on, working QMS.
- Gap assessment
- eQMS setup
- Training
- Rollout
Submissions and strategy
Predicate analysis, pathway assessment, and the writing itself. If the route you've picked is the wrong one, you'll hear it before you spend a year on it.
- 510(k)
- De Novo
- Technical files
- EU MDR
- Health Canada
Audit readiness
Mock audits run the way the real ones are run, including the questions people hope won't get asked. Plus CAPA strategy, and response drafting when a finding has already landed.
- Mock audits
- MDSAP
- CAPA
- 483 response
Post-market surveillance
Reportability decisions you can defend, and the surveillance system behind them — built once across EU MDR and FDA rather than maintained twice.
- PMS plans
- PSUR
- Vigilance
- Complaint trending
§ 2 Applicability
When companies call us
Rarely because they want a consultant. Usually because one of these just became true.
- Deadline A 483 or a nonconformity landed, and the response window is measured in days.
- Audit The notified body arrives in six weeks and the technical file is not ready.
- First time There has never been a QMS, and the first submission is on next year's plan.
- Outgrown The system was built for one product. There are now four, and two of them don't fit.
- Integration Three sites came in through an acquisition and have to run on one quality system.
- Coverage The head of quality left, and the seat has to stay filled while you hire.
Either way
We scope to what's actually in front of you. That can mean one procedure reviewed in a week, or a full system built over two quarters. Both are real engagements here.
§ 3 Deliverables
Document programs
Complete, ready-to-adopt procedure sets. Each one arrives customized to your scope, your standard, and your eQMS — not as a template you have to finish yourself.
Post-market surveillance
PMS plan, PSUR template, vigilance work instruction, trend analysis procedure, and reporting forms. Aligned to EU MDR and FDA together.
CAPA and complaint handling
End-to-end CAPA procedure, complaint intake SOP, reportability decision tree, and effectiveness verification records.
Supplier qualification and control
Qualification packet, approved supplier list, audit criteria matrix, and the triggers that force re-qualification. Built to survive MDSAP.
Internal audit
Audit schedule, checklist library by clause, findings log, and corrective action follow-through. Works across multiple sites.
Full quality system
The complete procedure framework for your scope and standard, from first draft through controlled release and training records.
Pricing
Programs are quoted by scope, not by hour. Tell us your device class, markets, and standard, and you'll get a fixed number.
Request a quote
§ 4 Method
How an engagement runs
Four stages, in order, every time — because skipping the first one is how consultants end up building the wrong thing beautifully.
Assess
We read what you already have and find where it breaks — against the standard, and against how your team actually works.
Prioritize
A written plan, ordered by regulatory risk and your calendar. You see what we'd do first and why before anyone starts drafting.
Build
Documents drafted, submissions written, reviews run. Your team reviews as we go, so nothing arrives as a surprise at the end.
Hand over
Training, records, and the reasoning behind each decision — so the system holds after we leave. Retainer support if you want it.
§ 5 Normative references
Standards we work in
The frameworks behind the documents. If your market isn't listed, ask — the routes overlap more than they look like they do.
- FDA QMSR
- 21 CFR 820
- ISO 13485
- 2016
- ISO 14971
- Risk management
- IEC 62304
- Software lifecycle
- EU MDR
- 2017/745
- EU IVDR
- 2017/746
- MDSAP
- Five jurisdictions
- EUDAMED
- UDI and registration
- 510(k) and De Novo
- FDA submissions
- Health Canada
- MDEL and MDL
- UKCA
- MHRA registration
- Swissmedic
- MedDO
§ 6 Contact
Tell us what's due, and when.
One procedure or a whole system, six weeks out or six months — send the deadline and the scope and you'll get a straight answer on whether we're the right fit.
Email
info@kairosqrs.com
Based in
South Florida — working nationwide and remote
Response
Within one business day